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Bladder Cancer - Phase IIb Clinical Trial - Inclusion/Exclusion Criteria


Inclusion Criteria

To be eligible to participate in this study, patients must:

  • Provide written informed consent.
  • Have intermediate-risk recurrent superficial TCC of the bladder defined as Stage Ta (low or high grade) or T1 (but with penetration into no more than ½ of the lamina propria), low grade (grade 1 or grade 2), as confirmed by histopathology, and have not recurred within 3-months of a complete course of a prior acceptable therapy (i.e., 6-weekly intravesical administrations of BCG or standard adjuvant treatment with thiotepa, doxorubicin, epirubicin, valrubicin, or mitomycin C). 
  • Have complete resection of all papillary tumors with the exception of a single superficial papillary tumor that is appropriate to be a marker tumor (up to 1.0 cm in diameter).
  • Have 2-7 tumors visible during cystoscopy and no tumor larger than 3cm in diameter.
  • Have at least one tumor specimen resected before the start of the study that was positive for H19 expression by ISH.
  • Have failed at least one prior standard intravesical treatment including chemotherapy with mitomycin C, thiotepa, valrubicin, doxyrubicin, or epirubicin, or immunotherapy with BCG. Failure after treatment with chemotherapy is defined as recurrent disease after at least one intravesical instillation of drug. Failure after treatment with BCG is defined as intolerance to treatment such that treatment was discontinued or after having received 6 or more BCG instillations there is recurrent or persistent disease 3 or more months after initiation of BCG treatment. NOTE: Intravesical administration of chemotherapy immediately following TUR as per standard practice, is not considered standard intravesical adjuvant treatment.
  • Have a Karnofsky’s performance status of at least 60%.
  • Have adequate bone marrow reserve:  Hemoglobin > 10 g/dL, WBC >= 3000/mm3, and platelets > 100,000 /mm3 within 8 weeks prior to study entry. 
  • Have adequate renal function with serum creati­nine less than 1.5 times the laboratory upper limit of normal (ULN) within 8 weeks prior to study entry.
  • Have adequate liver function with serum biliru­bin, AST/SGOT and ALT/SGPT less than twice the laboratory ULN within 8 weeks prior to study entry.
  • Be at least 18 years of age.
  • If male, agree to use a condom, if sexually active. If female, agree to practice one of the following acceptable methods of birth control or be surgically sterile or postmenopausal (greater than 1 year post last menstrual cycle): oral contraceptives, barrier (diaphragm or condom), patch, intrauterine progesterone contraceptive system, levonorgestrel implant, medroxyprogesterone acetate contraceptive injection, complete abstinence from sexual intercourse.

Exclusion Criteria

To be eligible to participate in this study, patients must not:

  • Have a current diagnosis or history of Stage T1 (high grade) or Stage T2 or higher or CIS.
  • Have severe concomitant disease that might limit compliance or completion of the protocol.
  • Have a tumor in a diverticulum, in the prostatic urethra, or covering the ureteral orifice.
    Have any other malignancy that might impact 5-year survival or might be potentially confused with TCC.
  • Have congenital or acquired immune deficiencies.
  • Be receiving cytotoxic drugs or systemic corticosteroids within 2 weeks of receiving the first intravesical administration of investigational product.
  • Have received intravesical therapy within 8 weeks prior to study entry.
  • Have received radiation therapy for their bladder cancer at any time or any other conditions including pelvic irradiation for any condition within 4 months prior to study entry.
  • Have active infections (including urinary tract infections) defined as viral, bacterial, or fungal infections requiring therapy, HIV-positive status, concurrent febrile illness, or gross hematuria.
  • Have biopsy, TUR, or traumatic catheterization within 14 days of start of treatment.
  • If female, be pregnant or breast feeding.
  • Have participated in any therapeutic research study within the last 8 weeks.
  • Have participated in any other gene therapy study including patients who have received DTA-H19/PEI in the past.

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